Abstract
Current convention requires log 6 reduction of spore-based biological indicators to demonstrate the efficacy of hydrogen peroxide vapour sanitisation cycles. Data is presented indicating that this is not an appropriate challenge and that a lower log reduction requirement offers significant advantages. A standard challenge of log 4 reduction is proposed.

Standards

New standards for assessing the suitability of equipment and materials for use in cleanrooms: ISO 14644 Parts 14 and 15
Isabelle Tovena-Pecault, Delphine Faye

Abstract
One of the main difficulties facing a cleanroom manager is whether or not to accept a particular material or piece of equipment in the cleanroom without risk to production. In the absence of any international standard, different industries, such as space and lasers, have chosen their own specifications.

This paper gives an overview of two international standards, currently in the latter stages of development, for assessing the suitability of equipment and materials for use in cleanrooms. ISO 14644-14 and ISO 14644-15 will consider particulate and chemical contamination, respectively.

Energy management for cleanrooms: The development of a new ISO standard: ISO 14644 Part 16
Dick Gibbons

Abstract
This article discusses the activity of the UK and ISO Working groups preparing the ISO Standard for the management of cleanroom energy.

Regulatory Reflections

Biocidal Products Regulation – ‘cleaning up the marketplace’: Guide to the new regulations covering bio-decontamination claims and processes in Europe
John Chewins

Abstract
Applying to all biocidal products, EU regulation 528/2012 Biocidal Products Regulation (BPR)i came into force in September 2013. The regulation is designed to control the selling or ‘placing on the market’ of biocidal products. It involves the analysis of a biocidal product’s performance (efficacy), toxicity, environmental fate and risk during use. This paper aims to summarise some of the key points raised when sourcing BPR approved products.